A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise

GlaxoSmithKline (GSK)

Status and phase: Withdrawn; Phase 3

Conditions: Asthma

Treatments: Drug: Fluticasone Propionate Inhalation Powder; Drug: Fluticasone Furoate/Vilanterol Inhalation Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT01435902

106847

Details and patient eligibility

About

The primary objective of this study is to demonstrate that the combination of inhaled fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection throughout the day against bronchoconstriction induced by exercise compared with fluticasone propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with persistent asthma.

Sex: All

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatient male or female 12 to 50 years of age
• Females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
• Diagnosis of persistent asthma for at least 6 months
• Best pre-bronchodilator FEV1 of at least 70%.
• Current use of a low- to moderate-dose inhaled corticosteroid
• Ability to withhold albuterol 6 hours prior to visits.
• Physically able to perform exercise testing on a treadmill when albuterol has been withheld

Exclusion criteria

• Intermittent asthma, seasonal asthma, or exercise-induced asthma only
• Symptomatic allergic rhinitis and/or thrush
• Abnormal, clinically significant electrocardigraph
• Respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
• Asthma exacerbation within 12 weeks of first visit
• Respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation
• Investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study
• Allergy to study drugs or study drug excipients
• Concomitant medications that could interact with study medications or affect the course of asthma
• Tobacco use within last year and/or a 10 pack-years history
• Inability to comply with requirements of the study
• Affiliation with investigator's site (example: family member)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Fluticasone Furoate/Vilanterol

Active Comparator group

Description:

Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 4 weeks

Treatment:

Drug: Fluticasone Furoate/Vilanterol Inhalation Powder

Fluticasone Propionate

Active Comparator group

Description:

Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 4 weeks

Treatment:

Drug: Fluticasone Propionate Inhalation Powder